CLASS II Drug recall · Reported 9 Feb 2022 · FDA Enforcement Report
Doxylamine Succinate and Pyridoxine Hydrochloride recalled
Teva Pharmaceuticals USA is recalling Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, distributed nationwide in the US. The recall was initiated on 18 Jan 2022 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-0461-2022
- FDA event ID
- 89422
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jan 2022
- FDA classified
- 28 Jan 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
Timeline
| 18 Jan 2022 | Recall initiated by company | |
| 28 Jan 2022 | Classified by FDA | +10 days |
| 9 Feb 2022 | 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
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Which lots are affected?
Lot# 100025842, 100028023, Exp Date 08/2023
Where was it sold?
Nationwide in the USA
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.
More recalls from Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
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| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Doxylamine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Doxylamine Succinate and Pyridoxine HCl Delayed-Release recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Bionpharma | Other | Nationwide |