CLASS II Drug recall · Reported 8 Sep 2021 · FDA Enforcement Report
Cyclobenzaprine Hydrochloride Tablets, 7.5mg tablets recalled
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets, 7.5mg tablets per, distributed nationwide in the US. The recall was initiated on 29 Jul 2021 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-0775-2021
- FDA event ID
- 88370
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2021
- FDA classified
- 27 Aug 2021
- Reported
- 8 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
Timeline
| 29 Jul 2021 | Recall initiated by company | |
| 27 Aug 2021 | Classified by FDA | +29 days |
| 8 Sep 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Product as listed by the FDA
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
Where it was distributed
Product was distributed nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Which lots are affected?
1408822A, exp. date 08/2023 (labeler - Casper)
Where was it sold?
Product was distributed 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 88370| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cyclobenzaprine Hydrochloride Tablets, 7.5mg tablets recalled | Teva Pharmaceuticals USA | Mold | Nationwide | |
| CLASS II | Cyclobenzaprine Hydrochloride Tablets, 7.5mg tablets recalled | Teva Pharmaceuticals USA | Mold | Nationwide |
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|---|---|---|---|---|---|
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Other Cyclobenzaprine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg recalledCyclobenzaprine Hydrochloride | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Cyclobenzaprine Hydrochloride Tablets, 7.5mg tablets recalled | Teva Pharmaceuticals USA | Mold | Nationwide |
| Drug | CLASS II | Cyclobenzaprine Hydrochloride Tablets, 7.5mg tablets recalled | Teva Pharmaceuticals USA | Mold | Nationwide |
| Drug | CLASS II | Cyclobenzaprine HCl Tablets, USP, 5 mg Unit Dose recalled by Apace KY | Apace KY | Other | KY |
| Drug | CLASS II | Cyclobenzaprine HCL, Tablet, 5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |