CLASS II Drug recall · Reported 23 May 2018 · FDA Enforcement Report
Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalled
Prescript Pharmaceuticals is recalling Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers, distributed in California. The recall was initiated on 24 Apr 2018 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-0806-2018
- FDA event ID
- 79961
- Recalling firm
- Prescript Pharmaceuticals, Pleasanton, CA
- Manufacturer
- Aurolife Pharma, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2018
- FDA classified
- 14 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 24 Apr 2018 | Recall initiated by company | |
| 14 May 2018 | Classified by FDA | +20 days |
| 23 May 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Product as listed by the FDA
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033
Where it was distributed
California.
Questions about this recall
Is Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalled?
Yes. Prescript Pharmaceuticals recalled Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers on 24 Apr 2018. The recall is Class II and its status is Terminated. Recall number D-0806-2018.
Why was it recalled?
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Which lots are affected?
Lot # 0130131, EXP 8/31/20
Where was it sold?
California.
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.
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| Drug | CLASS II | Clindamycin, USP M-Pak containers recalled by Prescript Pharmaceuticals | Prescript Pharmaceuticals | Other | CA |
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| Drug | CLASS II | Chlorhexidine 12% liquid, 473 Milliters recalled | Prescript Pharmaceuticals | Other | CA |
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Other Acetaminophen recalls
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|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |
| Drug | CLASS I | Acetaminophen Extra Strength Tablets, 500 mg each recalledAcetaminophen | A-S Medication Solutions | Labeling Errors | Nationwide |