CLASS II Drug recall · Reported 12 Jun 2013 · FDA Enforcement Report
Metronidazole Tablets, USP, 500 mg recalled by Physicians Total Care
Physicians Total Care is recalling Metronidazole Tablets, USP, 500 mg, distributed nationwide in the US. The recall was initiated on 6 Apr 2011 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-547-2013
- FDA event ID
- 65269
- Recalling firm
- Physicians Total Care, Tulsa, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2011
- FDA classified
- 4 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Antibiotics
Timeline
| 6 Apr 2011 | Recall initiated by company | |
| 4 Jun 2013 | Classified by FDA | +790 days |
| 12 Jun 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146.
Where it was distributed
Nationwide
Questions about this recall
Is Metronidazole Tablets, USP, 500 mg recalled?
Yes. Physicians Total Care recalled Metronidazole Tablets, USP, 500 mg on 6 Apr 2011. The recall is Class II and its status is Terminated. Recall number D-547-2013.
Why was it recalled?
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Which lots are affected?
Entry Format for Lots is: PTC Lot #; Exp Date; Distributor Bulk Lot #. PTC Lot #614S; Exp 05/31/2013; Teva Lot #14108110A. PTC Lot #6HFC; Exp 06/30/2013; Teva Lot #14127710A. PTC Lot #615S; Exp 08/31/2013; Teva Lot #14180910A. PTC Lot #4614; Exp 04/30/2011; Barr Lot #306670. PTC Lot #46TQ; Exp 04/30/2011; Barr Lot #306670. PTC Lot #48GN; Exp 05/31/2011; Barr Lot #307039. PTC Lot #4A36; Exp 05/31/2011; Barr Lot #307127. PTC Lot#4AA9; Exp 05/31/2011; Barr Lot #307127. PTC Lot #4ASM; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4AWE; Exp 05/31/2011; Barr Lot# 307128. PTC Lot #4AWG; Exp 05/31/2011; Barr Lot#307128. PTC Lot#4AZR; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4B72; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4C50; Exp 06/30/2011; Barr Lot #307360. PTC Lot# 4BOZ; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4BPO; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4E2R; Exp 07/31/2011; Barr Lot #307901. PTC Lot #4D68; Exp 08/31/2011; Barr Lot #307953. PTC Lot #4ETP; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4F8Y; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4F8Z; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4FCP; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4GCM; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4GY4; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4HR8; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4HZ4; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4IE9; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4J14; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JBR; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JN3; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JQ0; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4KFL; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4KT7; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4L2L; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4LWK; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MAL; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MEY; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MX9; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4NBB; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4NBZ; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4O56; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4ORJ; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4PEJ; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4PL1; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4QQF; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4R6O; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4RSK; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4S1U; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4SFI; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4SRT; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4TB2; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4U8D; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4V2G; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4VJG; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4X6N; Exp 12/31/2011; Barr Lot #311069. PTC Lot #4Y9Q; Exp 12/31/2011; Barr Lot #311069. PTC Lot #4XVB; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4XZH; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4Y9P; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5031; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5172; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5698; Exp 12/31/2011; Barr Lot #311074. PTC Lot #56NJ; Exp 12/31/2011; Barr Lot #311074. PTC Lot #56NL; Exp 12/31/2011; Barr Lot #311074. PTC Lot #58XM; Exp 12/31/2011; Barr Lot #311074. PTC Lot #59D2; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4WEJ; Exp 01/31/2012; Barr Lot #311075. PTC Lot #527Z; Exp 12/31/2011; Barr Lot #311145. PTC Lot #52FT; Exp 12/31/2011; Barr Lot #311145. PTC Lot #5328; Exp 12/31/2011; Barr Lot #311145. PTC Lot #53CU; Exp 12/31/2011; Barr Lot #311145. PTC Lot #54AE; Exp 12/31/2011; Barr Lot #311145. PTC Lot #557T; Exp 12/31/2011; Barr Lot #311145. PTC Lot #55QA; Exp 02/28/2012; Barr Lot #311365. PTC Lot #563R; Exp 02/28/2012; Barr Lot #311365. PTC Lot #57WL; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5ASQ; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5BTD; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5BZ9; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5CCB; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5CO2; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5DXG; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5F86; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5KE5; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5KJS; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5KSX; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5DIO; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5DUW; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5H9T; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5HZ3; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5I1B; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5IJ2; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5J2T; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5LPO; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5ME4; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5MNG; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5N7Q; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5OC6; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5PRW; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5QOH; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5QOI; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5RGR; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5RGT; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5OLD; Exp 01/31/2013; Barr Lot #315019. PTC Lot #5TWL; Exp 01/31/2013; Barr Lot #315021. PTC Lot #5SXH; Exp 12/31/2012; Barr Lot #315023. PTC Lot #5T2J; Exp 12/31/2012; Barr Lot #315023. PTC Lot #5TWK; Exp 01/31/2013; Barr Lot #315181. PTC Lot #5U96; Exp 01/31/2013; Barr Lot #315181. PTC Lot #5VDI; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5VNI; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5W14; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5W9R; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5WNV; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOC; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOD; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOE; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5UHJ; Exp 02/28/2013; Barr Lot #315679. PTC Lot #5UUI; Exp 02/28/2013; Barr Lot #315679. PTC Lot #5ZKM; Exp 02/28/2013; Barr Lot #315836. PTC Lot #5ZKN; Exp 02/28/2013; Barr Lot #315836. PTC Lot #60CN; Exp 02/28/2013; Barr Lot #315836. PTC Lot #68C8; Exp 02/28/2013; Barr Lot #316205. PTC Lot #68U6; Exp 02/28/2013; Barr Lot #316205. PTC Lot #68UH; Exp 02/28/2013; Barr Lot #316205. PTC Lot #69QO; Exp 02/28/2013; Barr Lot #316205. PTC Lot #60NB; Exp 11/30/2012; Barr Lot #316241. PTC Lot #60UT; Exp 11/30/2012; Barr Lot #316241. PTC Lot #60UU; Exp 11/30/2012; Barr Lot #316241. PTC Lot #615Y; Exp 11/30/2012; Barr Lot #316241. PTC Lot #6168; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61KO; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61KP; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61RM; Exp 11/30/2012; Barr Lot #316241. PTC Lot #62CO; Exp 03/31/2013; Barr Lot #316298. PTC Lot #63CZ; Exp 03/31/2013; Barr Lot #316298. PTC Lot #63M7; Exp 03/31/2013; Barr Lot #316298. PTC Lot #64AW; Exp 03/31/2013; Barr Lot #316298. PTC Lot #64VH; Exp 03/31/2013; Barr Lot #316450. PTC Lot #6513; Exp 03/31/2013; Barr Lot #316450. PTC Lot #62HE; Exp 03/31/2013; Barr Lot #316622. PTC Lot #66KC; Exp 03/31/2013; Barr Lot #316626. PTC Lot #66KD; Exp 03/31/2013; Barr Lot #316626. PTC Lot #66MC; Exp 03/31/2013; Barr Lot #316626. PTC Lot #683O; Exp 03/31/2013; Barr Lot #316772. PTC Lot #6G1B; Exp 04/30/2013; Barr Lot #317017. PTC Lot #6G1C; Exp 04/30/2013; Barr Lot #317017. PTC Lot #69GY; Exp 03/31/2013; Barr Lot #317018. PTC Lot #69GZ; Exp 03/31/2013; Barr Lot #317018. PTC Lot #69H0; Exp 03/31/2013; Barr Lot #317018. PTC Lot #6G2G; Exp 05/31/2013; Barr Lot #317477. PTC Lot #6GOH; Exp 05/31/2013; Barr Lot #317479. PTC Lot # 494L; Exp 04/30/2011; Barr Lot #701252. PTC Lot #49K7; Exp 04/30/2011; Barr Lot #701252.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Physicians Total Care
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cephalexin Monohydrate Capsules,USP, 500 mg recalled | Physicians Total Care | Manufacturing (CGMP) Deviations | GA, MO |
| Drug | CLASS III | Loratadine 24 HR recalled by Physicians Total Care | Physicians Total Care | Other | Nationwide |
| Drug | CLASS II | Carisoprodol IV ( Carisoprodol Tablets USP) 350mg recalled | Physicians Total Care | Lead & Heavy Metals | 4 states |
| Drug | CLASS II | Belladonna Alkaloids/PB (Belladonna Alkaloids recalled | Physicians Total Care | Packaging Defects | GA |
| Drug | CLASS III | Voltaren 1% Gel, 100 gm tube recalled by Physicians Total Care | Physicians Total Care | Other | Nationwide |
Other Metronidazole recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metronidazole tablets, USP 250 mg unit dose recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metronidazole Injection, USP, 500 mg recalled by Claris Lifesciences | Claris Lifesciences | Sterility | Nationwide |
| Drug | CLASS II | METRONIDazole Injection, USP 500 mg (5 mg/mL) recalled | Hospira Inc., A Pfizer | Sterility | Nationwide |
| Drug | CLASS I | Metronidazole Injection USP, 500 mg recalled by Baxter HealthcareMetronidazole | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Metronidazole Injection USP, RTU, 500 mg recalled by Baxter HealthcareMetronidazole | Baxter Healthcare | Sterility | Nationwide |